CTRI/2025/08/092889招募中Unknown
A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of GolimuRel® (Golimumab manufactured by Reliance Life Sciences Pvt. Ltd.) in rheumatoid arthritis, psoriatic arthritis and ulcerative colitis
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 20
- 主要终点
- Incidence of adverse events occurring during the study.
研究概览
简要总结
This is prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of GolimuRel® in approved indications. In this study, a total of 225 patients with 75 patients in moderate to severe active rheumatoid arthritis, 75 patients moderate to severe psoriatic arthritis and 75 patients in moderate to severe ulcerative colitis will be enrolled to ensure 202 evaluable patients (considering a drop-out rate of 10%).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with rheumatoid arthritis psoriatic arthritis or ulcerative colitis as defined below Rheumatoid Arthritis Males and females aged 18 to 65 years inclusive Diagnosis of Rheumatoid Arthritis according to the criteria based on the revised 2010 American College of Rheumatology ACR European League Against Rheumatism EULAR classification criteria for Rheumatoid Arthritis Subjects must have ACR or EULAR diagnostic criteria score greater than or equal to 6 Subjects must have active disease as defined by Greater than or equal to 6 swollen joints Greater than or equal to 6 tender joints and Acute phase reactant values CRP greater than 8 mg per L or ESR greater than 28 mm per h Subject must have been treated with and tolerated MTX at a dose of at least 20 mg per week for at least 3 months prior to screening and have a stable MTX dose of greater than or equal to 20 mg per week and less than or equal to 25 mg per week for at least 4 weeks prior to first administration of study drug.
- •Subjects using oral corticosteroids must have been on a stable dose equivalent to less than or equal to 10 mg of prednisone per day for at least 2 weeks prior to first administration of study drug If currently not using corticosteroids the subject must not have received oral corticosteroids for at least 2 weeks prior to first administration of study drug Subjects using NSAIDs or other analgesics for RA must have been on a stable dose for at least 2 weeks prior to the first administration of study drug Patients must be considered eligible according to the following TB screening criteria Have no history of latent or active TB prior to screening Have no signs or symptoms suggestive of active TB upon medical history and per or physical examination.
- •Have had no recent close contact with a person with active TB or if there has been such contact patient should undergo thorough evaluation for TB prior to study enrolment Have no evidence of latent TB based on tuberculin skin Mantoux test QuantiFERON TB Gold test or other tuberculosis screening tests performed during screening Have no evidence of current active TB or old inactive TB based on chest radiograph at screening Screening laboratory test results Hemoglobin greater than or equal to 8.0 g per dL White blood cells greater than or equal to 3.5 into 109 per L Neutrophils greater than or equal to 1.5 into 109 per L Platelets greater than or equal to 100 into 109 per L ALT and AST levels less than or equal to 2 times the ULN Serum creatinine less than or equal to 150 µmol per L less than or equal to 1.7 mg per dL Psoriatic Arthritis Patients aged 18 years or older Active psoriatic arthritis greater than or equal to 3 swollen joints and greater than or equal to 3 tender joints in at least one of the following forms 1 DIP which is Distal interphalangeal involvement 2 Polyarticular arthritis absence of rheumatoid nodules and presence of psoriasis 3 Arthritis mutilans 4 Asymmetric psoriatic arthritis 5 Spondylitis like ankylosis Patients with plaque psoriasis with a lesion greater than or equal to 2 cm in diameter Ulcerative Colitis UC Patients aged 18 years or older Has a clinical diagnosis of Ulcerative Colitis UC at least 3 months prior to screening Has a current UC severity that is judged by the treating physician to be moderate to severe being a partial Mayo score of 5 to 9 inclusive Participants must have biopsy results collected at the screening endoscopy procedure or obtained within the last 1 year prior to screening consistent with the diagnosis of UC Participants either currently receiving treatment with or have a history of failure to respond to or tolerate at least 1 of the following therapies oral 5 aminosalicylate oral corticosteroids 6-mercaptopurine and azathioprine Participants with current dependency or with a history of corticosteroid dependency that is an inability to successfully taper corticosteroids without a return of the symptoms of UC 2 Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures eg abstinence oral contraceptives intrauterine device barrier method with spermicide surgical sterilization during the study and for 6 months after receiving the last administration of study drug Women of childbearing potential must test negative for pregnancy at screening 3 Menopausal females must have experienced their last period more than 12 months prior to screening to be classified as not of childbearing potential 4 Subject must be capable of providing informed consent which must have been obtained prior to any study related procedures 5 Subject must be able to understand the study procedures adhere to the study visit schedule and other protocol requirements and must be able to complete study related forms and questionnaires.
排除标准
- •If patients have any of the following conditions they are not eligible to participate in the study 1 Patients with hypersensitivity to golimumab or any component of the formulation Chinese hamster ovary cell products or other recombinant human or humanized antibodies 2 Inflammatory diseases other than RA that might confound the evaluation of the efficacy of golimumab eg psoriatic arthritis ankylosing spondylitis systemic lupus erythematosus or Lyme disease for RA only 3 Received infliximab adalimumab etanercept certolizumab tocilizumab rituximab or golimumab or any biological treatment of Rheumatoid Arthritis psoriatic arthritis or ulcerative colitis 4 Received DMARDs per systemic immunosuppressives eg leflunomide Dpenicillamine hydroxychloroquine chloroquine oral or parenteral gold sulfasalazine azathioprine cyclosporine mycophenolate mofetil anakinra or intraarticular IM or IV corticosteroids including adrenocorticotropic hormone within the 4 weeks prior to the first administration of study drug 5 Subjects with prior and current use of anakinra abatacept or biologic antitumor necrosis factor TNF agents 6 Participants with severe extensive UC that is likely to require a colectomy surgery to remove part or all of the colon within 12 weeks of study entry for UC only Participants having UC limited to the rectum only or to less than 20 centimeter of the colon for UC only 9 Presence of a stoma an artificial permanent opening especially in the abdominal wall made in surgical procedures or presence of a fistula for UC only 10 Received any investigational drug within 5 halflives prior to the first administration of study drug 11 Received herbal homeopathic ayurvedic or traditional medicines for rheumatoid arthritis psoriatic arthritis or ulcerative colitis within 1 months prior to the first administration of the study drug 12 History of or ongoing chronic or recurrent infectious disease including but not limited to chronic renal infection chronic chest infection eg bronchiectasis sinusitis recurrent urinary tract infection eg recurrent pyelonephritis chronic nonremitting cystitis an open draining or infected skin wound or an ulcer 13 History of a serious infection eg hepatitis pneumonia pyelonephritis or sepsis which caused hospitalization within 6 months prior to the first administration of the study drug or treated with IV antibiotics for an infection within 2 months prior to administration of study drug 14 Positive HIV HBsAg or HCV test at screening 15 History of active or latent granulomatous infection including TB histoplasmosis or coccidioidomycosis 16 Had a nontuberculous mycobacterial infection or opportunistic infection eg cytomegalovirus Pneumocystis carinii aspergillosis within 6 months prior to screening 17 Received or is expected to receive any live virus or bacterial vaccination within 3 months before the first administration of study drug or within 6 months after the last administration of study drug 18 Received or is expected to receive Bacille CalmetteGuerin BCG vaccination within 12 months before the first administration of study drug or within 6 months after the last administration of study drug 19 History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease eg lymphadenopathy of unusual size or location or clinically significant splenomegaly 20 Known history of malignancy or organ transplantation 21 Presence of any abnormality suggestive of a malignancy or current active infection including TB based on chest radiograph at screening 22 Known history of demyelinating disease such as multiple sclerosis or optic neuritis 23 Known history or current evidence of CHF 24 Known history of asthma COPD or any other clinically significant respiratory disease 25 Current signs or symptoms of severe progressive or uncontrolled renal hepatic hematologic gastrointestinal endocrine pulmonary cardiac neurologic psychiatric or cerebral disease 26 Known hypersensitivity to human immunoglobulin proteins or other components of golimumab 27 Had a substance abuse drug or alcohol problem within the previous 3 years 28 Participation in any clinical study of an investigational product within the previous 3 months 29 Pregnant nursing or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study drug.
结局指标
主要结局
Incidence of adverse events occurring during the study.
时间窗: Rheumatoid Arthritis & Psoriatic Arthritis - Screening, Day 0, Weeks 4, 8, 12, 16, 20 and 24 | Ulcerative Colitis - Screening, Day 0,Week 2 Weeks 6, 10, 14, 18, 22 and 24
次要结局
- Proportion of patients with an ACR 20, ACR 50 and ACR 70 response at(each visit through Week 24)
- Change from baseline in DAS 28 score at each visit through Week 24
- Change from baseline in CRP and ESR level at each visit through Week 24(Week 24)
- Change from baseline in HAQ-DI score at each visit through Week 24(Week 24)
- Improvement from baseline in Short Form 36 Health Survey Questionnaire (SF-36) score at Week 24(Week 24)
- Proportion of patients achieving the ACR 20, 50, and 70 response across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)(Weeks 4, 8, 12, 16, 20 and 24)
- Proportion of patients achieving PASI 50/75/90/100 response from baseline across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)(Weeks 4, 8, 12, 16, 20 and 24)
- Change in HAQ-DI score from baseline across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)(Weeks 4, 8, 12, 16, 20 and 24)
- Number of patients with Clinical Response at Week 10 and 24(Week 10 and 24)
- Number of patients with Clinical Remission at Week 10 and 24(Week 10 and 24)
- Number of patients with Mucosal Healing at Week 10 and 24(Week 10 and 24)
- Rheumatoid arthritis & Psoriatic Arthritis: Immunogenicity assessment at Weeks 0, 12 and 24 or withdrawal visit(Weeks 0, 12 and 24 or withdrawal visit)
- Ulcerative colitis: Immunogenicity assessment at Weeks 0, 10 and 24 or withdrawal visit(Weeks 0, 10 and 24 or withdrawal visit)
研究者
Dr Ajaykumar Yadav
Reliance Life Sciences
研究点 (20)
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